What is 21 CFR 820 l Quality System Regulation l The Learning Reservoir

In this video, we delve into the essential details of 21 CFR Part 820, also known as the Quality System Regulation (QSR) set by the U.S. Food and Drug Administration (FDA).

21 CFR 820 is a set of regulations issued by the FDA that outlines the current good manufacturing practices (cGMPs) for medical devices. The regulation is titled "Quality System Regulation" and it defines the requirements for the design, manufacturing, packaging, labeling, storage, installation, and servicing of medical devices intended for human use.

The purpose of 21 CFR 820 is to ensure that medical devices are safe and effective for their intended use, and that they meet the quality standards set by the FDA. The regulation covers a wide range of topics, including device design controls, document controls, corrective and preventive actions, device labeling and packaging, and complaint handling procedures.

Medical device manufacturers are required to comply with 21 CFR 820 in order to market their products in the United States. Compliance with this regulation is typically verified through inspections and audits conducted by the FDA or third-party organizations. Failure to comply with 21 CFR 820 can result in enforcement actions such as product recalls, fines, or even criminal charges.

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👉 If you want to learn more about the Quality System Regulation, consider taking one of our QSR courses. We offer flexible delivery methods.
21 CFR 820 eLearning courses: https://bit.ly/3KWtiMv
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🔔 𝗙𝗥𝗘𝗘 𝗲𝗕𝗼𝗼𝗸: 𝗘𝘃𝗲𝗿𝘆𝘁𝗵𝗶𝗻𝗴 𝘆𝗼𝘂 𝗻𝗲𝗲𝗱 𝘁𝗼 𝗸𝗻𝗼𝘄 𝗮𝗯𝗼𝘂𝘁 𝗠𝗗𝗦𝗔𝗣🔔

MDSAP stands for "Medical Device Single Audit Program". It is a program that allows medical device manufacturers to undergo a single audit that satisfies the quality management system requirements of multiple regulatory jurisdictions. These jurisdictions include Australia, Brazil, Canada, Japan, and the United States.

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